NATIONAL
INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES
AUTHORIZATION:
Public
Health Service Act, Sections 301, 405, 464L, 464N, and 464P, 42
U.S.C. 241, 42 U.S.C. 284, 42 U.S.C. 295, 42 U.S.C. 2850-2, and
42 U.S.C. 2850-4; Small Business Research and Development Enhancement
Act of 1992, Public Law 102-564.
To
support epidemiologic, basic, clinical, and applied research to
develop new knowledge and approaches related to the prevention,
treatment, etiology, and consequences of drug addiction, including
HIV/AIDS. Small Business Innovation Research (SBIR) program: to
expand and improve the SBIR program. The legislation is intended
to expand and improve the SBIR programs to emphasize and increase
private sector commercialization of technology developed through
Federal SBIR research and development; increase small business participation
in Federal research and development; and foster and encourage participation
of socially and economically disadvantaged small business concerns
and women-owned small business concerns in the SBIR program. The
legislation intends that the Small Business Technology Transfer
(STTR) program stimulate and foster scientific and technological
innovation through cooperative research and development carried
out between small business concerns and research institutions; foster
technology transfer between small business concerns and research
institutions; to increase private sector commercialization of innovations
derived from Federal research and development; and foster and encourage
participation of socially and economically disadvantaged small business
concerns and women-owned small business concerns in technological
innovation.
TYPES
OF ASSISTANCE:
Project Grants. Place Cursor Here for Definition
USES
AND USE RESTRICTIONS:
(1) Research project grants
provide support for clearly defined projects or a small group of
related research activities, and when appropriate, support of research
conferences; (2) program project and center grants support large-scale,
broad-based programs of research, usually interdisciplinary, consisting
of several projects with a common focus; (3) small grants support
newer, less experienced investigators; investigators at institutions
without a well developed research tradition and resources; the testing
of new methods or techniques; small-scale exploratory and pilot
studies, or exploration of an unusual research opportunity; small
grants provide research support of up to $50,000 direct costs per
year for a period of up to 2 years; (4) SBIR Phase I grants (of
approximately 6-months' duration) are to establish the technical
merit and feasibility of a proposed research or research and development
efforts to determine the quality of performance of the small business
grantees. Phase II grants are for the continuation of the research
initiated in Phase I and that are likely to result in commercially
viable products or processes. Only Phase I awardees are eligible
to apply for Phase II support; STTR Phase I grants (normally of
1-year duration) are to determine the scientific, technical, and
commercial merit and feasibility of the proposed cooperative effort
that has potential for commercial application and the quality of
performance of the small business concerns. Phase II funding is
based on results of research initiated in Phase I and scientific
and technical merit and commercial potential of the Phase II application.
ELIGIBILITY REQUIREMENTS:
Applicant Eligibility:
Public or private profit and nonprofit agencies, foreign or domestic,
including State, local or regional government agencies, universities,
colleges, hospitals, and academic or research institutions may apply
for research grants. SBIR grants can be awarded only to domestic
small businesses (entities that are independently owned and operated
for profit, are not dominant in the field in which research is proposed,
and have no more than 500 employees). Primary employment (more than
one-half time) of the principal investigator must be with the small
business at the time of award and during the conduct of the proposed
project. In both Phase I and Phase II, the research and/or development
must be performed in the U.S. and its possessions. To be eligible,
an SBIR grant application must be approved for scientific merit
and program relevance by a scientific review group and by a national
advisory council. STTR grants can be awarded only to domestic small
business concerns (entities that are independently owned and operated
for profit, are not dominant in the field in which research is proposed
and have no more than 500 employees) which "partner" with a research
institution in cooperative research and development. At least 40
percent of the project is to be performed by the small business
concern and at least 30 percent by the research institution. In
both Phase I and Phase II, the research must be performed in the
U.S. and its possessions. To be eligible for funding, a grant application
must be approved for scientific merit and program relevance by a
scientific review group and a national advisory council.
Beneficiary Eligibility:
Public or private profit and nonprofit organizations.
Credentials/Documentation:
Costs will be determined in accordance with OMB Circular No. A-87
for State and local governments. For other grantees, costs will
be determined in accordance with HHS Regulation 45 CFR, Part 74,
Subpart Q. For SBIR and STTR grants, applicant organization (small
business concern) must present in a research plan an idea that
has potential for commercialization and furnish evidence that
scientific competence, experimental methods, facilities, equipment,
and funds requested are appropriate to carry out the plan. Grant
forms PHS 6246-1 and PHS 6246-2 are used to apply for SBIR Phase
I and Phase II, respectively. Grant forms PHS 6246-3 and PHS 6246-4
are used to apply for STTR Phase I and Phase II, respectively.
Pre-application
Coordination: Not applicable. This program is
excluded from coverage under E.O. 12372.
Application Procedure:
The standard application forms, as furnished by PHS and required
by 45 CFR 92 for State and local governments, must be used for
this program. Application kits containing the necessary forms
and instructions, if not available at the applicant institution,
may be obtained from the National Institutes of Health, Division
of Extramural Outreach and Information Resources, Bethesda, MD.
20892. They are also available from the NIH web site at www.nih.gov.
Information concerning NIDA and the types of research supported
may be found at www.drugabuse.gov or www.nida.nih.gov. Consultation
on a proposed project may also be obtained from NIDA. Applications
are reviewed by primarily nonfederal consultants recruited nationwide.
The amount of the award and period of support are determined on
the basis of scientific merit of the project as well as financial
and programmatic consideration. SBIR and STTR Grant Solicitations
and SBIR Contract Solicitation may be obtained electronically
through the NIH's "Small Business Funding Opportunities" home
page at http://www.nih.gov/grants/funding/sbir.htm on the World
Wide Web. A limited number of hard copies of these publications
are produced. Subject to availability, they may be obtained by
contacting the NIH support services contractor: phone: (301) 206-9385;
fax: (301) 206-9722; e-mail: a2y@cu.nih.gov. The Solicitations
include submission procedures, review considerations, and grant
application or contract proposal forms. SBIR and STTR grant applications
should be submitted to the Center for Scientific Review, 6701
Rockledge Drive, Room 1040 - MSC 7710, Bethesda, MD 20892-7710.
Award Procedure:
Research grants in support of projects recommended for approval
by the appropriate National Advisory Council and approved for
payment are awarded directly by NIDA to the applicant institution.
All accepted SBIR/STTR applications are evaluated for scientific
and technical merit by an appropriate scientific peer review panel
and by a national advisory council or board. All applications
receiving a priority score compete for available SBIR/STTR set-aside
funds on the basis of scientific and technical merit and commercial
potential of the proposed research, program relevance, and program
balance among the areas of research.
Deadlines:
February 1, June 1, and October 1, for R01, R03, R13, R21, P01,
P30, 50, and 60. January 2, May 1, and September 1 for AIDS research.
SBIR: April 1, August 1, and December 1. STTR: April 1, August
1, and December 1.
Range of Approval/Disapproval
Time: From 240 to 270 days from submission
of grant application. For AIDS applications the range will not
exceed 180 days from cited receipt dates. SBIR/STTR applications:
About 7-1/2 months.
Appeals:
A principal investigator (P.I.) may question the substantive or
procedural aspects of the review of his/her application by communicating
with the staff of the Institute. A description of the NIH Peer
Review Appeal procedures is available on the NIH home page www.nih.gov/grants/guide/notice-files/not97-232.html.
Renewals:
Support is recommended for a specified project period, usually
not in excess of 5 years. Prior to termination of a project period,
the grantee may apply for additional support via competing continuation
application unless otherwise restricted. Small grants are limited
to up to 2 years. Exploratory/developmental grants are limited
to 3 years.
ASSISTANCE CONSIDERATIONS:
Formula and Matching
Requirements: This program has no statutory
formula or matching requirements.
Length and Time Phasing
of Assistance: Varies, but a project period
is generally limited to 5 years or less. Grantee may apply for
renewal of support on a competing basis unless otherwise restricted.
Within the project period, continuation applications must be submitted
on a non-competing basis for each year of approved support. Small
grant support is limited to no more than 2 years. SBIR: Normally,
Phase I awards are for 6 months; normally, Phase II awards are
for 2 years. STTR: Normally, Phase I awards are for 1 year; normally,
Phase II awards are for 2 years.
POST ASSISTANCE REQUIREMENTS:
Reports:
Reports must be submitted as follows: 1) Interim progress reports
annually as part of a non-competing application for previously recommended
support; (2) terminal progress report within 90 days after end of
project support; (3) annual financial status report within 90 days
after termination of annual grant; and (4) immediate and full reporting
of any inventions.
Audits:
In accordance with the provisions of OMB Circular No. A- 133,
(Revised, June 24, 1997), "Audits of States, Local Governments,
and Non-Profit Organizations," nonfederal entities that expend
financial assistance of $300,000 or more in Federal Awards will
have a single or a program-specific audit conducted for that year.
Nonfederal entities that expend less than $300,000 a year in Federal
awards are exempt from Federal audit requirements for the year,
except as noted in Circular No. A-133. For nongovernmental grant
recipients, audits are to be carried out in accordance with the
provisions set forth in OMB Circular No. A- 133. In addition,
grants and cooperative agreements are subject to inspection and
audits by DHHS and other Federal officials.
Records:
Records must be retained for at least 3 years; records shall be
retained beyond the 3-year period if audit findings have not been
resolved.
FINANCIAL INFORMATION:
Account Identification:
75-0897-0-1-552.
Obligations:
(Grants) FY 01 $604,692,000; FY 02 est $673,994,000, and FY 03
est $729,438,000.
Range
and Average of Financial Assistance:
$19,000 to $4,634,000; Average: $353,000.
In fiscal year 2001, 1,688
grants were issued. In fiscal year 2002, an estimated 1,802 grants
are anticipated, and in fiscal year 2003, an estimated 1,849 grants
are anticipated.
REGULATIONS, GUIDELINES, AND
LITERATURE:
42 CFR 52; Guidelines
are included in applications kits. PHS Grants Policy Statement,
DHHS Publication No. (OASH) 94-50,000, (Rev.) April 1998. Grants
will be available under the authority of and administered in accordance
with the PHS Grants Policy Statement and Federal regulations at
42 CFR Part 52 and 42 CFR Part 52a; Omnibus Solicitation of the
Public Health Service for Small Business Innovation Research (SBIR)
Grant and Cooperative Agreement Applications. Omnibus Solicitation
of the National Institutes of Health for Small Business Technology
Transfer (STTR) Grant Applications.
INFORMATION CONTACTS:
Regional or Local
Office: Not applicable.
Headquarters Office:
Program Contacts: Dr. David Shurtleff, Acting Director, Division
of Neuroscience and Research (Basic Behavioral, Biomedical and
Neuroscience Research). Telephone: (301) 443-1887. Dr. Frank Vocci,
Director, Division of Treatment Research and Development (Research
on Treatment, Behavior, Clinical Neuroscience, AIDS, and Tuberculosis,
Medication Development, Drug Delivery Systems and Clinical Trial
Research). Telephone: (301) 443-6173. Dr. Wilson Compton, Director,
Division of Epidemiology, Services and Prevention Research (Incidence,
Prevalence, Ethnographic, Survey Research, and Longitudinal Studies
on Prevention, Vulnerability and Etiology, Health Services). Telephone:
(301) 443-6504. Dr. Henry Francis, Director, Center on AIDS and
Other Medical Consequences (AIDS and other Medical Consequences
). Telephone: (301) 443-1801. Dr. Lucinda Miner, Coordinator for
Research Training and Research Scientist Development. Telephone:
(301) 443-6071. SBIR Contact: Dr. Cathrine Sasek, Telephone: (301)
443-6071. Grants Management Contact: Dr. Gary Fleming, Grants
Management Officer. Telephone: (301) 443-6710. National Institute
on Drug Abuse, National Institutes of Health, Department of Health
and Human Services, Neuroscience Building, 6001 Executive Boulevard,
Bethesda, MD 20892. Use the same numbers for FTS.
Web Site Address: http://www.nih.gov
or
www.drugabuse.gov
EXAMPLES OF FUNDED PROJECTS:
(1) Kinetics of Morphine
and its Derivatives; (2) Epidemiology of drug abuse among minority
populations; (3) Studies of AIDS among IV Drug Abusers; (4) Studies
of Narcotic- Induced Respiratory Depression; (5) Endorphins: Metabolism,
Release, and Tolerance; (6) Biological and Behavior Mechanisms of
Addictive and Compulsive Behavior; and (7) Maternal/Paternal Effects
of Drugs of Abuse.
CRITERIA FOR SELECTING PROPOSALS:
The following considerations
will be used in determining projects to be funded: (1) Scientific
and technical merit; (2) the feasibility of the research; (3) potential
contribution to the national drug abuse problem; and (4) relevance
to NIDA priorities. The following criteria will be used in considering
the scientific and technical merit of SBIR/STTR Phase I grant applications:
(1) The soundness and technical merit of the proposed approach;
(2) the qualifications of the proposed principal investigator, supporting
staff, and consultants; (3) the technological innovation of the
proposed research; (4) the potential of the proposed research for
commercial application; (5) the appropriateness of the budget requested;
(6) the adequacy and suitability of the facilities and research
environment; and (7) where applicable, the adequacy of assurances
detailing the proposed means for (a) safeguarding human or animal
subjects and/or (b) protecting against or minimizing any adverse
effect on the environment. Phase II grant applications will be reviewed
based upon the following criteria: (1) The degree to which the Phase
I objectives were met and feasibility demonstrated; (2) the scientific
and technical merit of the proposed approach for achieving the Phase
II objectives; (3) the qualifications of the proposed principal
investigator, supporting staff, and consultants; (4) the technology.
